Fluoxetine v. placebo in prevention of relapse in post-traumatic stress disorder.

BACKGROUND Little is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder (PTSD) relapse. AIMS To assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse. METHOD This was a double-blind, randomised, placebo-controlled study. Following 12 weeks of acute treatment, patients who responded were rerandomised and continued in a 24-week relapse prevention phase with fluoxetine (n=69) or placebo (n=62). The primary efficacy assessment was the prevention of PTSD relapse, based on the time to relapse. RESULTS Patients in the fluoxetine/fluoxetine group were less likely to relapse than patients in the fluoxetine/placebo group (P=0.027). There were no clinically significant differences in treatment-emergent adverse events between treatment groups. CONCLUSIONS Fluoxetine is effective and well tolerated in the prevention of PTSD relapse for up to 6 months.